Radiopacity Testing per ASTM F640-12
ENSURING ADEQUATE RADIOPACITY is of great importance in the biomedical and life science fields. Tracking the devices and confirmation of positioning in vivo is essential, therefore the level of visibility of materials or product with X-ray techniques such as fluoroscopy, angiography, X-ray computed tomography (CT), and DEXA (dual energy X-ray absorptiometry) must be determined.
Medical Murray can assist you in conducting radiopacity testing and other fluoroscopy services to improve catheter performance and function. We can help evaluate new or existing medical device projects in a clinically relevant way.
ASTM F640-12 Radiopacity Testing
Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, and (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.
The ASTM standard has three test methods:
Method A—Radiopacity is determined as a specific difference in optical density between the image of the plastic and the background on the X-ray film or equivalent.
Method B—Radiopacity is determined by comparing the images of the test piece and of a standard piece simulating the medical device.
Method C—The intrinsic radiopacity of a plastic is determined by measurements made on the image of a slab of a specific thickness of the formulation.
We also offer additional testing with our versatile mini C-arm imaging technology including:
- Imaging artifact analysis
- Catheter inspection
- Visualization of internal components or defects
- Product performance testing
- Deployment testing
- Bench testing for physician directed studies
Please contact us today for further information. Our experienced engineers look forward to working with you on your Radiopacity and fluoroscopic imaging testing requirements. We also develop and validate custom test protocols that conform with required ISO and FDA standards.